Catalog Number 5100015250 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2023 |
Event Type
malfunction
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Event Description
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This report summarizes 4 malfunction events in which the device or cutting accessory fractured.4 events had no patient involvement; no patient impact.
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 4 events were reported for this quarter.Product return status: 4 devices were received.Additional information: 4 devices were not labeled for single-use.4 devices were not reprocessed or reused.
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 5 previously reported events are included in this follow-up record.Product return status: 4 devices were received.1 device was not available for evaluation.
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Event Description
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This report summarizes 5 malfunction events in which the device or cutting accessory fractured.4 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
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Event Description
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This report summarizes 5 malfunction events in which the device or cutting accessory fractured.- 4 events had no patient involvement; no patient impact.- 1 event had patient involvement; no patient impact.
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h6, h10 4 events were previously reported during the reporting quarter; however, - 1 previously reported event was included under mfr report # 3015967359-2023-01710 but should be included under this report.- 5 previously reported events are included in this follow-up record.
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Search Alerts/Recalls
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